FDA-Drug2021-07-28Class III

Acetaminophen EXTRA STRENGTH Pain Reliever / Fever Reducer, Enteric Coated, 50 Coated Tablets/ 500 mg each, Distributed by Amerisource Bergen, 1300 Morris Drive, Chesterbrook, PA, 19087, NDC 46122-649-71

LNK International, Inc.
Hazard

Labeling: Not Elsewhere Classified The primary label contains the words "enteric coated" but the tablet is not enteric coated and should only say 'coated tablet'

Sold states
Distributed in PA
Affected count
8,472 bottles
Manufactured in
55 Arkay Dr, N/A, Hauppauge, NY, United States
Products
Acetaminophen EXTRA STRENGTH Pain Reliever / Fever Reducer, Enteric Coated, 50 Coated Tablets/ 500 mg each, Distributed by Amerisource Bergen, 1300 Morris Drive, Chesterbrook, PA, 19087, NDC 46122-649-71

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0665-2021

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